Observational Study of the Safety, Tolerability and Efficacy of Tetrahydrocannabinol-Cannabidiol Oro-buccal Sprays, MC-1019 and MC-1022

Medlab Clinical Ltd0 个研究点目标入组 1,000 人开始时间: 2022年8月17日最近更新: 2022年9月19日

适应症

试验速览

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•1. Patients who have been prescribed MC-1019 and/or MC-1022 for a condition that is not multiple-sclerosis-related spasticity, or seizures associated with Lennox-Gastaut syndrome and Dravet syndrome.
•2. Prospective participants greater than or equal to 18 years of age at time of entry on study
•3. Prospective participants have the cognitive ability to understand the informed consent process and to give informed consent to participate in the observational study;
•4. Prospective participants are eligible to be lawfully prescribed MC-1019 and/or MC-1022 by the Participating Doctor;
•5. Prospective participants are able to visit their Participating Doctor’s clinic as required while being treated with MC-1019 and/or MC-1022 and are able to provide information as required for the duration of the study;
•6. Prospective participants agree to abstain from using cannabis products other than MC-1019, and/or MC-1022 for the duration of their participation in the study.

•1. Prospective participants will be ineligible if they have been prescribed MC-1019 and/or MC-1022 for a condition that is multiple-sclerosis related spasticity, or seizures associated with Lennox-Gastaut syndrome and Dravet syndrome2.
•2. Prospective participants will be ineligible if they have a hypersensitivity to cannabinoids or to any of the study treatment excipients;
•3. Pregnant, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, or implanted progesterone rods stabilized for at least 3 months), or women who are planning on becoming pregnant. Estrogen-based oral contraceptives are not considered reliable forms of contraception during this study due to drug interaction with CBD;
•4. Prospective participants judged by the Principal Investigator to be ineligible for participation as study participants for any reason;
•5. Prospective participants will be ineligible if they are unwilling or unable to perform study procedures as described in the study protocol.
•6. Prospective participants will be ineligible if they have concurrent recreational or medicinal cannabinoid use (other than the study treatments).
•7. History of substance abuse

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